BEUDAMED
    FDA Adverse Event Death Summary report: N

    MERCI RETREIVER V 2.0 FIRM

    MDR report key: 2629651 · Received June 21, 2012

    Report

    Report Number
    2954917-2012-00050
    Event Type
    Death
    Date Received
    June 21, 2012
    Date of Event
    July 14, 2011
    Report Date
    June 21, 2012
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVIDENCE OF CONCENTRIC MEDICAL DEVICE MALFUNCTION AND THE DEVICE INSTRUCTIONS FOR USE LISTS RELATED POSSIBLE COMPLICATIONS. ALSO, THE CONCENTRIC MEDICAL DEVICE USE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT OUTCOME, THERE ARE OTHER FACTORS INDEPENDENT OF THE SUBJECT DEVICE (E.G., PATIENT FACTORS, DEVICE USE FACTORS, OTHER DEVICES EMPLOYED, DRUGS ADMINISTERED, ETC.) THAT ALSO MAY HAVE CAUSED OR CONTRIBUTED TO THE OUTCOME. BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. ALSO, BECAUSE THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED TO CONCENTRIC MEDICAL, THE MANUFACTURING RECORDS FOR THE MERCI RETRIEVER V 2.0 FIRM DEVICE COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PATIENT WAS A (B)(6) FEMALE WITH A RIGHT AND LEFT MIDDLE CEREBRAL ARTERY (MCA) M1 OCCLUSION WITH AN (B)(6) SCORE OF 34 PRE-OPERATIVELY. PHYSICIAN MADE TWO PASSES WITH A MERCI RETRIEVER V 2.0 FIRM FOR LEFT M1 OCCLUSION AND THEN TWO PASSES WERE MADE WITH A MERCI RETRIEVER V 2.0 SOFT FOR RIGHT M1 OCCLUSION. PATIENT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2C AFTER TREATMENT. A HEMORRHAGE WAS NOTICED POST-OPERATION ON A CT SCAN. PATIENT EXPIRED ONE DAY POST-PROCEDURE. T-PA WAS NOT ADMINISTERED TO THE PATIENT DURING PROCEDURE. PHYSICIAN BELIEVES THAT THE HEMORRHAGE IS DUE TO REVASCULARIZATION OF THE OCCLUDED VESSELS AND THAT THE DIRECT CAUSE OF THE PATIENT'S OUTCOME IS CEREBRAL HERNIA. PHYSICIAN ALSO STATED THAT WHETHER THE PROCEDURE WITH MERCI RETRIEVERS AFFECTED THE PATIENT'S OUTCOME OR NOT IS UNKNOWN. MEDICAL INTERVENTION WAS NOT PERFORMED DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETREIVER V 2.0 FIRM CATHETER, PERCUTANEOUS NRY CONCENTRIC MEDICAL, INC. 90110 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| O